MANA RBM entitled its entry, “Implementing Risk-Based Monitoring and Remote Trial Management Technologies and Processes to enable a Small Biotech to run a 1000 subject Phase IV study with a Clinical/DM staff of Four” to illustrate how Risk-Based Monitoring can be adopted in any size organization and within trial budgets.

MANA RBM worked with a small biotech to implement a wide variety of technology systems including:

EDC system as eSource,

electronic patient diary, randomization,

electronic Investigator Site Files and electronic Trial Master File,

Data repository with custom Risk-Based Monitoring Reports including reports for High Risk Data elements and a unique tool for Source Data Review in a data repository.

In addition to setting up all of these tools for the Sponsor, MANA RBM developed all processes and plans and trained both the Sponsor and Sites to adopt and use the tools. MANA RBM also performed co-monitoring and co-data management as well as central monitoring functions.

Dr. Manasco, CEO MANA RBM, stated, “We’re honored Clinical Informatics News named MANA RBM as finalist in its Best Practices contest. Tremendous opportunities exist to fully use technology in achieving organizational goals, but implementing technology is often daunting. Our entry showed how we worked with different vendors and different systems to develop and use different data and reports than those traditionally used in study analysis.”

MANA RBM helped the Sponsor select cost effective solutions to meet its needs within budgetary constraints. This trial demonstrated that adopting Risk-Based Monitoring (RBM) does not require a huge organization or large capital outlays over and above trial costs.

By configuring all the systems to work together, training the Sponsor, and supporting its adoption of these methods, the Sponsor was able to rapidly implement RBM without additional costs.

Dr. Manasco also stated, “By working together to deliver a product that included technology, processes, and staff training, a small biotech is more empowered to do trials itself or to implement future trials using more flexible and cost effective staffing approaches.”

The winner of this award will be announced at the SCOPE conference on February 24, 2016. If you would like to learn more about how you can adopt these methods, please contact Penelope Manasco, M.D., CEO MANA RBM at pmanasco@manarbm.com or at MANARBM.com.